Nurofen Cold and Flu

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist have told you.

• Keep this leaflet. You may need to read it again.
• Ask your pharmacist if you need more information or advice.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
• You must talk to a doctor if you do not feel better or if you start to feel worse.

1. What this medicine is and what it is used for
2. What you need to know before you take this medicine
3. How to take this medicine
4. Possible side effects
5. How to store this medicine
6. Contents of the pack and other information

• clears a blocked nose and sinuses
• relieves aches, pains, headache and high temperature (fever)
• eases the discomfort of a sore throat.

• are allergic to ibuprofen, pseudoephedrine or any of the other ingredients of this medicine (listed in section 6) or to aspirin or other non-steroidal anti-inflammatory drugs
• have had a worsening of asthma, skin rash, itchy runny nose or facial swelling when previously taking aspirin or similar medicines
• have (or have had two or more episodes of) a stomach ulcer, perforation or bleeding
• have had gastrointestinal bleeding or perforation when previously taking (non-steroidal anti-inflammatory drugs) (NSAIDs).
• are taking other NSAID painkillers or more than 75 mg aspirin a day
• have severe heart disease or very high blood pressure (severe hypertension) or hypertension not controlled by your medication
• have severe acute (sudden) or chronic (long term) kidney disease or kidney failure
• have severe heart or liver problems
• are under 12 years of age.
• are taking Monoamine Oxidase Inhibitors (for depression and known as MAOIs) or have taken these in the last 14 days.
• have a phaeochromocytoma.

• have asthma
• have Systemic Lupus Erythematosus (SLE)- an illness affecting the immune system causing joint pain, skin changes and other problems
• have liver or kidney problems, especially in dehydrated children and adolescents, as kidney problems can be made worse
• have high cholesterol or have previously had a heart attack or a stroke
• have a history of gastrointestinal disease (such as ulcerative colitis, Crohn’s disease)
• are a smoker
• have an over-active thyroid
• are diabetic, have glaucoma or prostate problems
• reduction of blood flow to your optic nerve may occur with this medicine. If you develop sudden loss of vision, stop taking this medicine and contact your doctor or seek medical attention immediately. See section 4.
• have an infection - please see heading 'Infections' below.

Infections

This medicine may hide signs of infections such as fever and pain. It is therefore possible that this medicine may delay appropriate treatment of infection, which may lead to an increased risk of complications. This has been observed in pneumonia caused by bacteria and bacterial skin infections related to chickenpox. If you take this medicine while you have an infection and your symptoms of the infection persist or worsen, consult a doctor without delay.

Skin reactions

Serious skin reactions including exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), acute generalised exanthematous pustulosis (AGEP) have been reported in association with ibuprofen treatment. Stop using this medicine and seek medical attention immediately, if you notice any of the symptoms related to these serious skin reactions described in section 4.

This medicine may affect or be affected by some other medicines. For example:

• medicines that are anti-coagulants (i.e. thin blood/prevent clotting e.g. aspirin/acetylsalicylic acid, warfarin, ticlopidine) as their affects may be increased
• medicines that reduce high blood pressure (ACE-inhibitors such as captopril, beta-blockers such as atenolol medicines, angiotensin-II receptor antagonists such as losartan) and diuretics as this medicine can reduce the effects of these drugs.
• Corticosteroids, anti-platelet agents and selective serotonin reuptake inhibitors (SSRIs) as there is an increased risk of gastrointestinal bleeding
• Cardiac glycosides used to stimulate the heart.
• medicines for depression (lithium, selective serotonin uptake inhibitors may affect or be affected by treatment with pseudoephedrine
• Methotrexate as this medicine can increase plasma levels of these drugs
• Ciclosporin & tacrolimus as there is an increased risk of kidney problems
• This product should not be taken within 8-12 days of taking Mifepristone (for termination of pregnancy)
• Zidovudine (for HIV treatment)
• Quinolone antibiotics
• When using Monoamine oxidase inhibitors (MAOIs) (e.g. moclobemide) and/or Reversible inhibitors of monoamine oxidase A (RIMAs), or within 14 days of stopping treatment with these medicines
• Ergot alkaloids (ergotamine & methysergide)
• Other sympathomimetic agents such as decongestants, amphetamine-like psychostimulants and appetite suppressants, as their effect may be increased by the pseudoephedrine contained in this medicine
• Oxytocin as there is a risk of increase in blood pressure.
• Anticholinergics as they can affect the way that pseudoephedrine works.
• Linezolid (medicine used to treat bacterial infections) as this may increase blood pressure

Some other medicines may also affect or be affected by the treatment of this medicine. You should therefore always seek the advice of your doctor or pharmacist before you use this medicine with other medicines.

• This medicine belongs to a group of medicines which may impair fertility in women. This is reversible on stopping the medicine. It is unlikely that this medicine, used occasionally, will affect your chances of becoming pregnant. However, tell your doctor before taking this medicine if you have problems becoming pregnant.
• Anti-inflammatory/pain-killer medicines such as ibuprofen may be associated with a small increased risk of heart attack or stroke, particularly when used at high doses. Do not exceed the recommended dose or duration of treatment.
• Sudden abdominal pain or rectal bleeding may occur with this medicine, due to inflammation of the colon (ischaemic colitis). If you develop these gastro-intestinal symptoms, stop taking this medicine and contact your doctor or seek medical attention immediately. See section 4.
• You should discuss your treatment with your doctor or pharmacist before taking this medicine if you:
  • have heart problems including heart failure, angina (chest pain), or if you have had a heart attack, bypass surgery, peripheral artery disease (poor circulation in the legs of feet due to narrow or blocked arteries), or any kind of stroke (including ‘mini-stroke’ or transient ischaemic attack ‘TIA’).
  • have high blood pressure, diabetes, high cholesterol, have a family history of heart disease or stroke, or if you are a smoker.
• If you develop a feverish generalised erythema associated with pustules, stop taking this medicine and contact your doctor or seek medical attention immediately. See section 4.
• Cases of posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS) have been reported following use of medicines containing pseudoephedrine. PRES and RCVS are rare conditions that can involve reduced blood supply to the brain. Stop using this medicine immediately and seek immediate medical assistance if you develop symptoms that may be signs of PRES or RCVS (see section 4 "Possible side effects" for symptoms).
• If you are taking this medicine for longer than the recommended time or at higher than recommended doses you are at risk of serious harm. These include serious harm to the stomach/gut and kidneys, as well as very low levels of potassium in your blood. These can be fatal (see section 4).

This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially 'sodium-free'.

If symptoms persist or pain or fever worsen, or if any new symptoms occur, consult your doctor or pharmacist.

If you have taken more of this medicine than you should, or if children have taken this medicine by accident always contact a doctor or nearest hospital to get an opinion of the risk and advice on action to be taken.The symptoms can include nausea, stomach pain, vomiting (may be blood streaked), headache, ringing in the ears, confusion and shaky eye movement. At high doses, drowsiness, chest pain, palpitations, loss of consciousness, convulsions (mainly in children), weakness and dizziness, blood in urine, cold body feeling, and breathing problems have been reported.

• Signs of intestinal bleeding such as:
  • bright red faeces (stools/motions), black tarry stools, vomiting blood or dark particles that look like coffee grounds.
• Signs of serious allergic reaction such as:
  • Difficulties in breathing
  • Dizziness or faster heartbeat
  • Signs of hypersensitivity and skin reactions such as reddish non-elevated, target-like or circular patches on the trunk, often with central blisters, skin peeling, ulcers of mouth, throat, nose, genitals and eyes. These serious skin rashes can be preceded by fever and flu-like symptoms (exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis).
  • Swelling of your face, tongue or throat
• signs of aseptic meningitis with neck stiffness, headache, feeling sick, being sick, fever or consciousness. Patients with autoimmune disorders (lupus, mixed connective tissue disease) may be more likely to be affected.
• a severe skin reaction known as DRESS syndrome can occur.
  Symptoms of DRESS include: skin rash, fever, swelling of lymph nodes and an increase of eosinophils (a type of white blood cells).
• sudden onset of fever, reddening of the skin, or many small pustules (possible symptoms of Acute Generalised Exanthematous Pustulosis - AGEP) that may occur within the first 2 days of treatment with this medicine. See section 2.
• A red, scaly widespread rash with bumps under the skin and blisters mainly localised on the skin folds, trunk, and upper extremities accompanied by fever at the initiation of treatment (acute generalised exanthematous pustulosis). See also section 2.
• inflammation of the colon due to insufficient blood supply (ischaemic colitis) (frequency not known).

• indigestion, heartburn or feeling sick
• pains in your stomach (abdomen) or other abnormal stomach problems
• hallucinations, restlessness or sleep disturbance

Like all medicines, this medicine can cause side-effects, although not everybody gets them. Tell your doctor or pharmacist if you notice any of the following:

• Liver, kidney problems or difficulty urinating

This medicine, especially when taken at higher than recommended doses or for a prolonged period of time, can cause damage to your kidneys and affect them removing acids properly from your blood into the urine (renal tubular acidosis). It can also cause very low levels of potassium in your blood (see section 2). This is a very serious condition and will require immediate treatment. Signs and symptoms include muscle weakness and light-headedness.

Uncommon: may affect up to 1 in 100 people:

• allergic reactions, such as skin rashes (urticaria), itching, peeling
• headaches, tremors

Rare: may affect up to 1 in 1,000 people:

• flatulence (wind), diarrhoea, constipation and vomiting

Very rare: may affect up to 1 in 10,000 people:

• blood disorder resulting in unexplained or unusual bruising or bleeding, fever, sore throat, mouth ulcers, flu-like symptoms and severe exhaustion
• drop in blood pressure or irregular heart beat
• stomach or intestinal ulcers, sometimes with bleeding and perforation, inflammation of the lining of the mouth with ulceration (ulcerative stomatitis), inflammation of the stomach (gastritis)
• Liver and kidney problems, characterised by yellowing of the skin or eyes; swollen hands, legs, ankles or feet; dark-coloured or bloody urine; pale, bloody or tar like stools; fatigue; shortness of breath; decreased appetite; or tendency to bruise easily.

Not known: frequency cannot be estimated from the available data:

• serious conditions affecting blood vessels in the brain known as posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS)

Stop using this medicine immediately and seek urgent medical attention if you develop symptoms, that may be signs of posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS). These include:

• severe headache with a sudden onset
• feeling sick
• vomiting
• confusion
• seizures changes in vision
  • worsening of asthma or bronchospasm
  • swelling (oedema), high blood pressure, heart failure or attack, chest pain (which can be a sign of a potential allergic reaction called Kounis Syndrome)
  • worsening of colitis and Crohn's disease or dry mouth
  • decreased appetite, anxiety
  • excessive sweating, muscle weakness, difficulty in urinating, thirst
  • Reduced blood flow to the optic nerve (Ischaemic optic neuropathy).
  • skin becomes sensitive to light

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

By reporting side effects, you can help provide more information on the safety of this medicine.